Supv, Quality - QC

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

To ensure all activities in laboratory are performed as per approved Standard operating procedure
To ensure all testing is being performed as per approved test procedure

To investigate any Out of specifications (OOS) or Non-conformity Report or Laboratory Incident and take the corrective and preventive actions (CAPA) if required

To review daily reports from staff documenting completion of tasks as assigned.

To review and timely approve the documents assigned in Team Center Unified (TcU).

To work with Analysts and Reviewers to implement compliant GMP and Good Documentation Practice (GDP) practices, review issues and impact of the same, and take corrective actions.
To ensure the calibration of all the instruments perform as per the schedule and approval of the same.

To train team members on current good manufacturing practices (GMP), Good Documentation Practices and good laboratory practice (GLP).

After review of completed Test Reports and Standard Formats, submit the results. Notify and initiate appropriate QMS event occurrence sequence if the reported data is out of trend or out of specifications. Escalate to the QC Operation Manager to determine a course of action for additional review and investigation.

To report and escalate as appropriate critical non-conformances immediately to the QC Operation Manager, IPQA, QMS and Production team

To work for lab readiness for audit and ensure compliance in Laboratory.

To come out with the suggestion on further enhancement for laboratory system and facilities.

To ensure the laboratory compliance in line with regulatory guideline and requirements.

To ensure timely release of Validation/ Method Transfer Document and report.

To provide the response to the internal and external audit observations and ensure their closure.

To support external audit process as per role assigned by QC Operation Manager or QC & Stability Head.

To share observations various inspections and follow up with stakeholders for holistic implementation of CAPA.

To Co-ordinate consultant visit and/or Mock Audit at site as part of Inspection Readiness

To communicate if any abnormality/gap/risk observed during document review, internal audit or laboratory round to QC Operation Manager.

To attend plant level internal meetings

To review and approve testing and monitoring to assure quality of Raw material, Packing Material, In-process products, finished products, Validation samples or any other samples.
To approve QC document after completion of analysis and reviewed.

To periodically check selected GMP records of raw data, GMP records of masters and change controls to verify that a robust security measures are being followed for access control and for adequate maintenance of data authenticity and data integrity.

To regularly review critical quality attributes of components and products and monitor/review OOT data maintained by staff members from assigned section to proactively identify product quality attribute shifts.

To perform daily and biweekly laboratory walk-through and as needed reviews to monitor and maintain sustained GMP compliance.

To monitor periodic trends and implement effective CAPAs that lead to a reduction in adverse trends year-on-year.

To respond promptly to information related to ANDA templates and associated queries received from IRA function as requested.

To be involved in Investigations Management of OOSs, OOTs, LIRs, Deviations, CCNs, Customer Complaints, CAPA.

To notify QC Operation Manager of any major inquiries and/or specific information requests. Immediately escalate any data integrity related issues to the QC Operation Manager.

To identify and quantify areas of potential quality improvement in processes, systems and/or documentation and present to QC Operation Manager

To implement, maintain, and approve systems, procedures, and standards to maintain, monitor, and continuously improve the state of quality and GMP compliance of the Laboratory Section regarding testing of In Process and Finished Product or other samples.

To ensure data integrity is maintained in laboratory.

To execute corrective and preventive actions (CAPA) and check effectiveness of CAPA

To ensure the implementation of current Good Manufacturing Practices, Good Documentation Practices and Good Laboratory Practices norms in Laboratory.

To take suggestions from QC Operation Manager regarding CAPA (Corrective and Preventive Action) as per requirement and ensure its implementation within stipulated timeframe and effectiveness of CAPA.
To ensure implementation of change control management (CCMs), Document Change Request (DCR) wherever necessary after getting it approved from QA.

In the absence of QC Analysis Supervisor, Quality Control Operation Manager will ensure these roles and responsibilities.

To attend the OOS review board meetings/Quality Meetings and work towards reduction of QMS elements in Laboratory.

To review and approve SOPs and Standard Formats for executing QC Chemistry work tasks ensuring these are current and meet company and international regulations.

To be involved in Investigations Management of OOSs, OOTs, LIRs, Deviations, CCNs, Customer Complaints, CAPA

To monitor various departmental activities as a shift in charge (Including Any troubleshooting in analysis, escalations, technical inputs), in all three shifts as a designee to the department head.

To bring to the notice about any abnormalities and non-conformity to QC Operation Manager and QA Head.

To perform any other task assigned by Quality Control Operation Manager.

To act as shift in charge and monitor activities in lab in all running shifts and take appropriate action as and when required.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
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